Trastuzumab Versus Lapatinib as Neoadjuvant Treatment for Her2+ Patients

NCT00841828 | Completed Phase 2 Results

• 2 other identifiers: GEICAM/2006-142007-007031-13
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 26

Brief Summary

Phase II randomized multicenter trial to compare Epirubicin and Cyclophosphamide plus Docetaxel and Trastuzumab with Epirubicin and Cyclophosphamide plus Docetaxel and Lapatinib for patients with positive HER2 and resectable or locally advanced breast cancer.

Conditions

Breast Cancer

Keywords

HER2-positive breast cancer; Lapatinib; Neoadjuvant; Trastuzumab; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Complete Pathological Response (pCR) Rate in Breast and Axilla According to the Miller&Payne Criteria (G5-A and G5-D).

  Within 3-4 weeks after last docetaxel dose the surgery was performed to evaluate pathological response. According to the Miller\&Payne Criteria, pCR in node-negative patients is a grade 5-A and in node-positive patients is a grade 5-D.

  Up to 16 weeks

Secondary Outcomes (1)

• Overall Clinical Response Rate (ORR)

  Up to 12 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

Epirubicin + Cyclophosphamide -\> Docetaxel + Lapatinib

Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Docetaxel; Drug: Lapatinib

Control

ACTIVE COMPARATOR

Epirubicin + Cyclophosphamide -\> Docetaxel + Trastuzumab

Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Docetaxel; Drug: Trastuzumab

Interventions

Epirubicin DRUG

Also known as: Ellence, Pharmorubicin

Control; Experimental

Cyclophosphamide DRUG

Also known as: Cytoxan, Neosar, Endoxan

Control; Experimental

Docetaxel DRUG

Also known as: Taxotere

Control; Experimental

Lapatinib DRUG

Also known as: Tykerb

Experimental

Trastuzumab DRUG

Also known as: Herceptin

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signature of the written informed consent.
• Histological documentation of breast cancer.
• Stage I (T1, N0M0), IIA (T2N0M0); IIB (T2N1M0, T3N0M0), IIIA (TXN2M0) and IIIB (T3N1M0, T4NXM0) primary resectable breast cancer or locally advanced breast cancer.
• HER2-positive breast cancer, defined as immunohistochemistry (IHQ) 3+ or positive FISH. When IHQ 2+ HER2 status must be assessed by FISH.
• The patient granted her consent for taking a biopsy before treatment
• The patient granted her consent for sending two tumor samples to central laboratory for molecular sub study.
• Two weeks prior randomization pregnancy test negative for women of childbearing potential.
• Women of childbearing potential must use adequate contraceptive measures during participation into study. Oral, injectable or implant hormonal contraceptives measure are not permitted.
• A World Health Organization (WHO) performance status of 0 or 1 (Karnofsky ≥ 80)
• Age \> 18 years.
• Absence of metastases disease
• Baseline Electrocardiography (EKG) 12 weeks prior to randomization. Baseline left ventricular ejection fraction (LVEF) value within limit of normal value for the institution or \> 50% of basal value
• Normal laboratory test 2 weeks prior to randomization:
• Haematology values: Neutrophil count ≥ 1,5 x109/l; Platelets ≥ 100 x 109/l; Haemoglobin ≥ 10mg/dl Biochemistry values: serum total bilirubin ≤ 1 x Upper Limit of Normal (ULN); Aspartate aminotransferase (AST) (SGOT) and Alanine aminotransferase (ALT) (SGPT) ≤ 2,5 x ULN; alkaline phosphatase ≤ 5 x ULN. Patients which AST and/or ALT value are \> 1,5 x ULN along with alkaline phosphatase value \> 2,5 x ULN will be not included into the study.
• Renal function: serum creatinine ≤ 175 µmol/l (2 mg/dl). If the value is borderline, clearance creatinine must be ≥ 60 ml/min

You may not qualify if:

• Patients with lumpectomy, partial mastectomy, modified radical mastectomy are not allowed to include into study.
• Prior Immunotherapy, hormonal therapy and chemotherapy for breast cancer is not allowed.
• Prior therapy with anthracycline and taxanes (paclitaxel and docetaxel) is not permitted for any neoplasia.
• Prior radiotherapy for breast cancer.
• Bilateral invasive breast carcinoma
• Pregnant or nursing patients. Negative pregnant test (serum or urine) 14 days prior to randomization.
• HER 2 negative breast cancer
• Patients of childbearing potential must be use adequate contraceptive measures during study treatment. No hormonal contraceptive measure is permitted.
• Any M1 breast cancer
• Any motor or sensorial neurotoxicity grade ≥ 2 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.
• Serious cardiac illness or medical conditions: Congestive heart failure, angina pectoris requiring specific treatment, myocardial infarction 1 year prior to enroll in the study; poorly controlled hypertension or high-risk uncontrolled arrhythmias.
• History of significative neurological or psychiatric disease (psychotic, dementia or attack) what is unable to patient to grant her informed consent.
• Uncontrolled severe Infection Uncontrolled diabetes mellitus, active peptic ulcer
• Current malignancy or previous malignancy other that breast cancer. Exception cell carcinoma of the skin no melanoma, carcinoma in situ of the cervix or any other cancer in the past 10 years.
• Corticoid use contraindication

Sponsors & Collaborators

• Spanish Breast Cancer Research Group: lead
• GlaxoSmithKline: collaborator

Study Sites (26)

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital General de Granollers

Granollers, Barcelona, 08400, Spain

Location

Xarxa Asistencial de Manresa

Manresa, Barcelona, 08243, Spain

Location

Corporación Sanitaria Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Hospital del Espíritu Santo

Santa Coloma de Gramenet, Barcelona, 08923, Spain

Location

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Hospital Mutua de Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Onkologikoa

Donostia / San Sebastian, Guipuzcoa, 20012, Spain

Location

Hospital Xeral Cíes

Vigo, Pontevedra, 36204, Spain

Location

Hospital Central de Asturias

Oviedo, Principality of Asturias, 33006, Spain

Location

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

Location

Complejo Hospitalario Universitario A Coruña

A Coruña, 15006, Spain

Location

Centro Oncológico de Galicia

A Coruña, 15009, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Clinic i Provincial

Barcelona, 08036, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital General Yagüe

Burgos, 09005, Spain

Location

Complejo Hospitalario San Pedro de Alcántara

Cáceres, 10003, Spain

Location

Complejo Hospitalario Universitario Reina Sofía

Córdoba, 14004, Spain

Location

Complejo Hospitalario de Jaén

Jaén, 23007, Spain

Location

Hospital Universitario de la Princesa

Madrid, 28006, Spain

Location

Hospital Clínico Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Virgen de la Salud

Toledo, 45004, Spain

Location

Hospital Universitario La Fe

Valencia, 46009, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Related Publications (1)

• Alba E, Albanell J, de la Haba J, Barnadas A, Calvo L, Sanchez-Rovira P, Ramos M, Rojo F, Burgues O, Carrasco E, Caballero R, Porras I, Tibau A, Camara MC, Lluch A. Trastuzumab or lapatinib with standard chemotherapy for HER2-positive breast cancer: results from the GEICAM/2006-14 trial. Br J Cancer. 2014 Mar 4;110(5):1139-47. doi: 10.1038/bjc.2013.831. Epub 2014 Jan 23.

  PMID: 24457911 RESULT

Related Links

• Sponsor's website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Epirubicin; Cyclophosphamide; Docetaxel; Lapatinib; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Emilio Alba
• Organization: Department of Medical Oncology, Hospital Universitario Virgen de la Victoria

emilioalbac@gmail.com

Study Officials

• Study Director

  Hospital Clínico Universitario de Valencia

  STUDY DIRECTOR

• Study Director

  Hospital Clínico Universitario Virgen de la Victoria

  STUDY DIRECTOR

• Study Director

  Hospital del Mar

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2009
• First Posted: February 11, 2009
• Study Start: February 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2013
• Last Updated: March 31, 2023
• Results First Posted: November 2, 2018

Record last verified: 2023-03

Locations

ES (26)